A comparison of two fixed doses of aripiprazole with placebo in acutely relapsed, hospitalized patients with bipolar disorder I (manic or mixed) in subpopulations (CN138-007) Rif S. El Mallakh a , ⁎ , Eduard Vieta b , Linda Rollin c , Ronald Marcus c , William H. Carson d , Robert McQuade d a University of Louisville, Louisville, KY, USA b Clinical Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain c Bristol-Myers Squibb, Wallingford, CT, USA d Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA Received 31 May 2010; received in revised form 14 July 2010; accepted 16 July 2010 KEYWORDS Acute mania; Bipolar disorder; Placebo response Abstract This study evaluated the efficacy and safety of two fixed doses of aripiprazole (15 mg/day, n = 131 and 30 mg/day, n = 136) compared with placebo (n = 134) in acutely manic or mixed bipolar I hospitalized patients. The mean change from baseline to Week 3 in the YMRS Total Scores was - 10.01 (95% CI: - 11.92, - 8.09) for aripiprazole 15 mg/day, - 10.80 (95% CI: - 12.71, - 8.90) for aripiprazole 30 mg/day, and - 10.12 (95% CI: - 12.01, - 8.24) for placebo. The most frequent adverse events (≥ 10% and greater than placebo) for either of the aripiprazole treatment groups were headache, nausea, dyspepsia, insomnia, agitation, constipation, akathisia, anxiety, lightheadedness, vomiting, diarrhea, asthenia and extremity pain. Aripiprazole 15 or 30 mg/day was not significantly more effective than placebo in the treatment of bipolar I disorder acute mania at endpoint (Week 3). A high placebo response rate may have accounted for the lack of separation between treatment groups. © 2010 Elsevier B.V. and ECNP. All rights reserved. 1. Introduction Bipolar I Disorder is a lifelong episodic illness characterized by manic and depressive episodes of varying severity, with subsyndromal and minor affective symptoms predominating (Judd et al., 2002). The lifetime prevalence of bipolar I ⁎ Corresponding author. Mood Disorders Research Program, Depart- ment of Psychiatry and Behavioral Sciences, University of Louisville, Louisville, KY 40292, USA. Tel.: +1 502 852 5866. E-mail address: rselma01@louisville.edu (R.S. El Mallakh). 0924-977X/$ - see front matter © 2010 Elsevier B.V. and ECNP. All rights reserved. doi:10.1016/j.euroneuro.2010.07.003 www.elsevier.com/locate/euroneuro European Neuropsychopharmacology (2010) 20, 776–783